NCT00158613

Study of the Treatment of Articular Repair (STAR)

A Prospective, Longitudinal Within-Patient Evaluation of the Effectiveness (Durability) of Carticel® (Autologous Cultured Chondrocytes) Compared to Non-Carticel Surgical Treatment for Articular Cartilage Defects of the Knee.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Vericel Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, longitudinal, multi-center, within patient evaluation of patients with articular cartilage defects of the knee who have had an inadequate response to a prior non-Carticel surgical treatment. Patients who met eligibility criteria were enrolled in the study. Subsequent to implantation with Carticel patients have follow-up every 6-months up to 48-months.

Conditions

• Articular Cartilage

Interventions

Type	Name	Description
BIOLOGICAL	Carticel (autologous cultured chondrocyte) implantation	Each Carticel vial of autologous cultured chondrocytes contains approximately 12 million cells implanted into the defect and secured with a periosteal flap

Timeline

• Start date: 2000-03-01
• Primary completion: 2005-11-01
• Completion: 2005-11-01
• First posted: 2005-09-12
• Last updated: 2021-05-11

Locations

28 sites across 2 countries: United States, Canada